FDA WARNING_LETTER - Intense Desire

The FDA's Center for Tobacco Products reviewed the website http://www.intensedesire.co.uk and determined that Intense Desire Atomic Fireball e-liquid products are offered for sale or distribution to U.S. customers. These e-liquids are classified as tobacco products under section 201(rr) of the FD&C Act.

The FDA found that Intense Desire Atomic Fireball e-liquid is misbranded under section 903(a)(7)(B) of the FD&C Act because it was sold to a person younger than 18 years of age. This violates 21 C.F.R. § 1140.14(b), which prohibits the sale of covered tobacco products, including e-liquids, to minors. The product is a "covered tobacco product" as defined by 21 C.F.R. § 1140.3.

The company must immediately correct this violation and any similar issues to ensure compliance with the FD&C Act and FDA's implementing regulations for all tobacco products, labeling, and advertising across all media. Failure to comply may result in further FDA action, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Adulterated and misbranded tobacco products imported into the U.S. are subject to detention.

A written response detailing corrective actions, including dates of